# DEN130016: XSTAT

- Pathway: De Novo (Direct)
- Applicant: Revmedx, Inc.
- Decided: Apr 3, 2014 after 428 days
- Product code: PGZ (Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use)
- Device class: 2
- Regulation: 21 CFR 878.4452
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K152624: Xstat 30, 3-Pack, Xstat 30, 1-Pack (2015), 5 descendants of its own
- K161020: XSTAT-12, 3-Pack, XSTAT-12, 1-Pack (2016), 4 descendants of its own
- K170334: XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack (2017), 3 descendants of its own
- K180051: XSTAT 30, 1-Pack (2018), 2 descendants of its own
- K210676: XSTAT 30 Pouch (2021), 1 descendant of its own

Source page: https://510kreport.com/device/DEN130016
Methodology: https://510kreport.com/methodology